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This is a Ⅱa clinical trial. The purpose of this study is to preliminarily explore the optimal dosage of Xinglou Chengqi Granules in the treatment of acute ischemic stroke and to evaluate the efficacy and safety of Xinglou Chengqi Granules for acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose group | Experimental | 16 g of Xinglou Chengqi granules will be given to participants in the high-dose group. |
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| Low-dose group | Active Comparator | 8 g of Xinglou Chengqi granules and 8 g of placebo will be given to participants in the low-dose group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose Xinglou Chengqi granules | Drug | Patients will receive orally high-dose Xinglou Chengqi granules, combined with guidelines-based standard care. |
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| Measure | Description | Time Frame |
|---|---|---|
| The change of NIHSS score from baseline to day 14. | The change of the National Institutes of Health stroke scale (NIHSS) score from baseline to day 14 will be analyzed between groups. | Baseline and Day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportions of patients with mRS ≤ 2 or mRS ≤ 1. | The proportions of patients with modified Rankin Scale (mRS) ≤ 2 or mRS ≤ 1 will be analyzed between groups. | Day 30, Day 60 and Day 90. |
| The change of NIHSS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinxing Lai, M.D. | Contact | +8615901111280 | new-star@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital, Beijing University of Chinese Medicine | Richmond | British Columbia | V7E 6J1 | Canada |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Low-dose Xinglou Chengqi granules and placebo | Drug | Patients will receive orally low-dose Xinglou Chengqi granules, combined with guidelines-based standard care. |
|
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The change of NIHSS score will be analyzed at days 7, 30, 60, and 90.
| Day 7, day 30, day 60, day 90. |
| The proportion of patients with Barthel Index score ≥ 95 or ≥ 75. | The proportion of patients with Barthel Index score ≥ 95 or ≥ 75 will be analyzed at days 7, 14, 30, 60, and 90. | day 7, day 14, day 30, day 60, day 90. |
| The change of EQ-5D score. | The change of EQ-5D score from baseline to days 7, 14, 30, 60, and 90 will be analyzed between groups. | day 7, day 14, day 30, day 60, day 90. |
| The incidence of new cardiovascular events. | The incidence of new cardiovascular events will be analyzed at day 7, 14, 30, 60, and 90. | day 7, day 14, day 30, day 60, day 90. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |